Peritoneal Cavity Conditioning Decreases Pain, Inflammation and Adhesions

October 24, 2016 updated by: Jasper Verguts, University Hospital, Gasthuisberg

Peritoneal Cavity Conditioning During Laparoscopic Surgery Decreases Postoperative Pain, Inflammatory Reaction and Postoperative Adhesions

Full conditioning of the peritoneal cavity during laparoscopic surgery will decrease post-operative pain, inflammation and adhesion formation.

Full conditioning will decrease an inflammatory response of the peritoneum and decrease pain and adhesion formation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Randomized controlled trial (RCT) comparing carbon dioxide to full conditioning (addition of oxygen, nitrous oxide, humidification and temperature control, dexamethasone and Hyalobarrier gel) Women undergoing laparoscopy for endometriosis, myomectomy or adhesiolysis will be randomized to either group and will be compared for pain (VAS scores); inflammation (White blood cells, CRP) and adhesions scored by second look laparoscopy.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women undergoing laparoscopic excision of deep endometriosis (stratum 1), excision of endometrioma's (stratum 2) or excision of uterine myoma's (stratum 3) since this is severe surgery, associated with severe postoperative adhesions and since for most of these women fertility is important and hence the second look laparoscopy can be beneficial.
  • Signed informed consent

Exclusion Criteria:

  • women with a pre-existing condition increasing the risk of surgery such as clotting disorders, heart or lung impairment etc.-Any condition that might interfere with inflammatory parameters such as immunodeficiency, chronic inflammatory disease as Crohn's disease.
  • Pregnancy
  • Conditions associated with chronic pain as peripheral neuropathy, pathology of the vertebral column and osteo-articular disease. Conditions causing acute pain e.g. abdominal trauma
  • a known allergic reaction to Hyalobarrier Gel Endo®
  • A bowel lesion requiring a single or double layer suture. (given that for none of the anti-adhesion barriers safety has been proven following bowel lesions and suture)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Full conditioing
Intervention by alteration of laparoscopic gas with addition of oxygen and nitrous oxide, regulation of humidification and temperature (32°C), injection of 5mg Dexamethasone and application of Hyalobarrier Gel Endo (Nordic Pharma) at the surgical wound
Procedure: full conditioning
addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C
Active Comparator: carbon dioxide
induction pneumoperitoneum with carbon dioxide 100%
Procedure: standard pneumoperitoneum
100% carbon dioxide used for the pneumoperitoenum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adhesion formation after laparoscopic surgery
Time Frame: 2 weeks after primary surgery
second look laparoscopy to assess adhesions formed after initial surgery
2 weeks after primary surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: recorded until 3 days after surgery
pain assessed by VAS scores
recorded until 3 days after surgery
inflammation
Time Frame: recorded until 3 days after surgery
bloodsamples to test for C reactive protein and white blood cells
recorded until 3 days after surgery
time to first flatus and stool
Time Frame: recorded until 3 days after surgery
patients will be asked when first flatus and first stool appeared. (measured as hours after surgery)
recorded until 3 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gasthuisberg

Investigators

  • Principal Investigator: Philippe Koninckx, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

April 21, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

October 25, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S52424

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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